MSD
Job Description
Join Our Team as a Biologics Drug Substance & Cell Banking Leader !
Are you ready to take your career to the next level? We are seeking a dynamic and visionary Biologics Drug Substance & Cell Banking Leader to spearhead our cutting-edge cell banking and biologics commercialization within the expansive Biologics S&T portfolio. Reporting directly to the Biologics Drug Substance Commercialization Leader, you will lead the Cell Banking working groups and drive innovation in biologics DS & cell bank manufacturing and commercialization projects.
Why You'll Love This Role:
As the Biologics Drug Substance & Cell Banking Leader, you’ll be at the forefront of scientific advancement, providing strategic and tactical technical direction through cross-functional partnerships with key business units and customers. Your leadership will be instrumental in supporting DS & cell bank commercialization, tech transfer, manufacturing, qualifications, licensure, and the launch of new DS & cell bank manufacturing sites. You’ll build the foundation for long-term robust manufacturing, enhance data monitoring capabilities, and drive excellence in safety, compliance, supply, and productivity.
Global Impact:
Collaborate with colleagues across the US and internationally to elevate standards in cell banking manufacturing, testing, and storage. Your work will shape the future of biologics on a global scale.
Key Responsibilities:
Technical Strategy:
Deliver robust DS & cell bank process and analytical strategies for successful commercialization. Provide technical oversight of DS & cell banking process development, process characterization and regulatory filing activities to ensure a smooth and clear path to successful PPQs and BLAs for the company's pipeline.
Technical leadership : Strong fundamental knowledge and subject matter expertise with mammalian cell culture processing of biologics (large molecule products), recent advances, and challenges in the field. Expertise in independently conducting and directing the planning, execution, analysis, and documentation of all stages of cell culture process commercialization. Risk assessment, control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions.
CMC RA : Experience supporting/writing regulatory filings (IND, MAA, BLA) and supporting inspections with multiple agencies (FDA, EMA, JNDA, TGA).
Leadership:
Establish and manage Cell Banking working groups, support CMC teams, and align resources to deliver on priorities. Manage and mentor a team of scientists specializing in biologics commercialization, serving as the scientific/technical mentor for junior staff. Action-oriented, mindset for creativity; ability to take initiative, innovate, iterate, and problem-solve.
Cross-Functional Collaboration:
Unite diverse teams to achieve program goals as One Team. Champion compliance and safety; promote a culture of diversity, inclusion, and equity. Experience and aptitude to lead, work, and collaborate in internal and external cross-functional, matrixed teams.
Problem Solving:
Remove roadblocks, resolve conflicts, and escalate issues when needed.
Communication:
Foster collaboration, ensure transparency, and engage with governance bodies. Excellent interpersonal and communication skills
Project Management:
Drive project schedules, set clear priorities, and monitor performance metrics. Adaptability and agility to prioritize and deliver complex objectives, often on tight timelines, in a rapidly changing environment.
Recognition:
Celebrate team achievements and foster a culture of appreciation.
Innovation:
Lead business improvement initiatives and leverage your network to drive change.
Education & Experience: Bachelor's degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with sixteen (16) years of relevant industry experience.
OR
Master's degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with twelve (12) years of relevant industry experience.
OR
Ph.D. in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with minimum eight (8) years or relevant industry experience.
What You Bring: Proven leadership of cross-functional teams in biologics development & commercialization
Deep expertise in cell culture and cell bank (master cell bank and working cell bank) manufacturing operations
Strong understanding of regulatory requirements
Ability to lead without authority, build trust, and inspire accountability
Ethical, resilient, and committed to excellence
Skilled in risk management, team facilitation, and strategic planning
Experience in commercial manufacturing and CMC development
Exceptional communication and stakeholder engagement skills
Equal Employment Opportunity Employer We provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.
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Deliver robust DS & cell bank process and analytical strategies for successful commercialization. Provide technical oversight of DS & cell banking process development, process characterization and regulatory filing activities to ensure a smooth and clear path to successful PPQs and BLAs for the company's pipeline.
Technical leadership : Strong fundamental knowledge and subject matter expertise with mammalian cell culture processing of biologics (large molecule products), recent advances, and challenges in the field. Expertise in independently conducting and directing the planning, execution, analysis, and documentation of all stages of cell culture process commercialization. Risk assessment, control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions.
CMC RA : Experience supporting/writing regulatory filings (IND, MAA, BLA) and supporting inspections with multiple agencies (FDA, EMA, JNDA, TGA).
Leadership:
Establish and manage Cell Banking working groups, support CMC teams, and align resources to deliver on priorities. Manage and mentor a team of scientists specializing in biologics commercialization, serving as the scientific/technical mentor for junior staff. Action-oriented, mindset for creativity; ability to take initiative, innovate, iterate, and problem-solve.
Cross-Functional Collaboration:
Unite diverse teams to achieve program goals as One Team. Champion compliance and safety; promote a culture of diversity, inclusion, and equity. Experience and aptitude to lead, work, and collaborate in internal and external cross-functional, matrixed teams.
Problem Solving:
Remove roadblocks, resolve conflicts, and escalate issues when needed.
Communication:
Foster collaboration, ensure transparency, and engage with governance bodies. Excellent interpersonal and communication skills
Project Management:
Drive project schedules, set clear priorities, and monitor performance metrics. Adaptability and agility to prioritize and deliver complex objectives, often on tight timelines, in a rapidly changing environment.
Recognition:
Celebrate team achievements and foster a culture of appreciation.
Innovation:
Lead business improvement initiatives and leverage your network to drive change.
Education & Experience: Bachelor's degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with sixteen (16) years of relevant industry experience.
OR
Master's degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with twelve (12) years of relevant industry experience.
OR
Ph.D. in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with minimum eight (8) years or relevant industry experience.
What You Bring: Proven leadership of cross-functional teams in biologics development & commercialization
Deep expertise in cell culture and cell bank (master cell bank and working cell bank) manufacturing operations
Strong understanding of regulatory requirements
Ability to lead without authority, build trust, and inspire accountability
Ethical, resilient, and committed to excellence
Skilled in risk management, team facilitation, and strategic planning
Experience in commercial manufacturing and CMC development
Exceptional communication and stakeholder engagement skills
Equal Employment Opportunity Employer We provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.
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